January 2020 FDA Recall Drug by Sigan Industries Inc.
D-0782-2020 - Microbial contamination of non-sterile product.

This Class III drug recall was voluntarily initiated by Sigan Industries Inc. on January 7, 2020 for the product Drug. The FDA reported the reason for recall as microbial contamination of non-sterile product.. The product was distributed in IL and the recall is currently terminated.

Recall Number: D-0782-2020

Reason for Recall
Microbial contamination of non-sterile product.
Initiated
01-07-2020
Reported
01-22-2020
Quantity
11,004 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
84678
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Sigan Industries Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
IL
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-12-2022
Product Description About Product Description
Full technical description of the product.
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.

Batch or Lot Expiration Information

Lot# : 2508-08-337, 2538-08-337, Exp 8/2020